Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD), 45000-45001 [2024-11256]
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45000
Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
NIH Summer Course in Clinical and Translational Research Course Evaluation (Attachment 6).
Sabbatical in Clinical Research Management Course
Evaluation (Attachment 7).
Ethical and Regulatory Aspects of Clinical Research
(Asynchronous/Online) Course (Attachment 8).
Total ........................................................................
Dated: May 16, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2024–11257 Filed 5–21–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
1,000
2,000
1,000
1,000
2,000
1,000
1,000
2,000
1,000
20
1
1
1
1
1
1
1
1
1
1
5/60
5/60
5/60
5/60
5/60
5/60
5/60
5/60
5/60
5/60
83
167
83
83
167
83
83
167
83
2
Healthcare Professionals ......
20
1
5/60
2
Healthcare Professionals ......
Students ................................
General Public ......................
100
50
100
1
1
1
5/60
5/60
5/60
8
4
8
...............................................
....................
21,290
....................
1,773
Proposed Collection; 60-Day Comment
Request; Post-Award Reporting
Requirements Including Research
Performance Progress Report
Collection (OD)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, for opportunity
for public comment on proposed data
collection projects, the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
SUMMARY:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Ms. Mikia P. Currie, Program
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
18:58 May 21, 2024
Analyst, Office of Policy for Extramural
Research Administration, 6705
Rockledge Drive, Suite 350, Bethesda,
Maryland 20892, or call a non-toll-free
number 301–435–0941 or email your
request, including your address to
ProjectClearanceBranch@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title: Public
Health Service (PHS) Post-award
Reporting Requirements Revision, OMB
0925–0002, Expiration Date 01/31/2026,
Office of the Director (OD), National
Institutes of Health (NIH).
Need and Use of Information
Collection: Starting in 2025, NIH will
SUPPLEMENTARY INFORMATION:
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
Healthcare Professionals ......
Students ................................
General Public ......................
Healthcare Professionals ......
Students ................................
General Public ......................
Healthcare Professionals ......
Students ................................
General Public ......................
Healthcare Professionals ......
IPPCR Final Course Evaluation (Attachment 4) ............
PCP Final Course Evaluation (Attachment 5) ...............
Jkt 262001
PO 00000
Total
annual
burden
hours
Number of
responses per
respondent
Type of respondents
PCP Lecture Evaluation (Attachment 3) ........................
Average
burden per
response
(in hours)
Estimated
number of
respondents
Form name
Frm 00045
Fmt 4703
Sfmt 4703
require applicable recipients to address
progress in association with their
approved Data Management and Sharing
Plans within the Research Performance
Progress Report (RPPR) in accordance
with the final NIH Policy for Data
Management and Sharing to promote
the management and sharing of
scientific data generated from NIHfunded or conducted research. The
progress report forms will be updated to
align with this requirement. The
Training Data Tables will also be
updated to reduce the burden and
promote consistent information
collection, including limiting the scope
of information collection to data only
relevant to the training stage(s) of the
proposed program in Table 1 and
removing instructions in Table 8 that
are reported within the RPPR. Effective
May 2025, NIH will be adopting the
Common Forms for Biographical Sketch
and Current and Pending (Other)
Support as part of the directive from
Guidance for Implementing National
Security Presidential Memorandum
(NSPM)-33. The Common Forms are
part of a separate OMB collection,
currently approved under 3145–0279.
As such, elements collected within the
Common Forms will be removed from
NIH’s current NIH Biosketch and Other
Support formats. NIH will continue to
collect additional information not
captured on the Common Forms to
adhere to the agency’s implementation
of the NIH Peer Review Regulations at
42 CFR part 52 as part of the NIH
Biosketch form, which will be renamed
the NIH Biosketch Supplement to reflect
the supplemental information
requested. The application and progress
E:\FR\FM\22MYN1.SGM
22MYN1
45001
Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
report forms and associated instructions
will be updated to align with these new
requirements. The RPPR is required to
be used by all NIH, Food and Drug
Administration (FDA), Centers for
Disease Control and Prevention, and
Agency for Healthcare Research and
Quality (AHRQ) grantees. Interim
progress reports are required to continue
support of a PHS grant for each budget
year within a competitive segment. This
collection also includes other PHS postaward reporting requirements: PHS
416–7 National Research Service Award
(NRSA) Termination Notice, PHS 2271
Statement of Appointment, 6031–1
NRSA Annual Payback Activities
Certification, HHS 568 Final Invention
Statement and Certification, and PHS
3734 Statement Relinquishing Interests
and Rights in a PHS Research Grant.
The PHS 416–7, 2271, and 6031–1 are
used by NRSA recipients to activate,
terminate, and provide for payback of an
NRSA. Closeout of an award requires a
Final Invention Statement (HHS 568)
and a Final Progress Report. The PHS
3734 serves as the official record of
grantee relinquishment of a PHS award
when an award is transferred from one
grantee institution to another. Pre-award
reporting requirements are
simultaneously consolidated under
0925–0001 and the changes to the
collection here are related.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
579,365.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Information collection forms
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total annual
burden hours
REPORTING
PHS 416–7 ......................................................................................................
PHS 6031–1 ....................................................................................................
PHS 568 ..........................................................................................................
PHS 2271 ........................................................................................................
PHS 2590 ........................................................................................................
RPPR–Core Data ............................................................................................
Biosketch (Part of RPPR) ................................................................................
Data Tables (Part of RPPR) ............................................................................
Trainee Diversity Report (Part of RPPR) ........................................................
PHS Human Subjects and Clinical Trial Information .......................................
Publication Reporting .......................................................................................
Final RPPR—Core Data ..................................................................................
Data Tables (Part of Final RPPR) ...................................................................
Trainee Diversity Report (Part of Final RPPR) ...............................................
PHS Human Subjects and Clinical Trial Information (Part of Final RPPR) ....
PHS 3734 ........................................................................................................
Data Management and Sharing Plan (Part of RPPR) .....................................
Data Management and Sharing Plan (Part of Final RPPR) ............................
12,580
1,778
11,180
22,035
243
32,098
2,544
758
480
6,420
97,023
18,000
758
480
3,600
479
15,649
8,621
1
1
1
1
1
1
1
1
1
1
3
1
1
1
1
1
1
1
30/60
20/60
5/60
15/60
18
8
2
4
15/60
3
5/60
10
4
15/60
4
30/60
2
2
6,290
593
932
5,509
4,374
256,784
5,088
3,032
120
25,680
24,256
180,000
3,032
120
14,400
240
31,298
17,242
Reporting Burden Total ............................................................................
........................
........................
........................
578,990
RECORDKEEPING
SBIR/STTR Life Cycle Certification .................................................................
1,500
1
15/60
375
Grand Total ...............................................................................................
236,226
........................
........................
579,365
Dated: May 9, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2024–11256 Filed 5–21–24; 8:45 am]
BILLING CODE 4140–01–P
khammond on DSKJM1Z7X2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, for opportunity
for public comment on proposed data
collection projects, the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
SUMMARY:
Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
DATES:
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; PHS Applications and PreAward Reporting Requirements (OD)
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
FOR FURTHER INFORMATION CONTACT:
AGENCY:
ACTION:
National Institutes of Health.
Notice.
VerDate Sep<11>2014
17:06 May 21, 2024
Jkt 262001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
information on the proposed project,
contact: Ms. Mikia P. Currie, Program
Analyst, Office of Policy for Extramural
Research Administration, 6705
Rockledge Drive, Suite 350, Bethesda,
Maryland 20892, or call a non-toll-free
number 301–435–0941 or email your
request, including your address to
ProjectClearanceBranch@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
E:\FR\FM\22MYN1.SGM
22MYN1
]]>Agencies
[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 45000-45001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11256]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Post-Award Reporting
Requirements Including Research Performance Progress Report Collection
(OD)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, for opportunity for public comment on proposed data
collection projects, the National Institutes of Health (NIH) will
publish periodic summaries of proposed projects to be submitted to the
Office of Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Ms. Mikia P.
Currie, Program Analyst, Office of Policy for Extramural Research
Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland
20892, or call a non-toll-free number 301-435-0941 or email your
request, including your address to [email protected].
Formal requests for additional plans and instruments must be requested
in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written comments and/or suggestions
from the public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) Ways to minimize
the burden of the collection of information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Public Health Service (PHS) Post-award
Reporting Requirements Revision, OMB 0925-0002, Expiration Date 01/31/
2026, Office of the Director (OD), National Institutes of Health (NIH).
Need and Use of Information Collection: Starting in 2025, NIH will
require applicable recipients to address progress in association with
their approved Data Management and Sharing Plans within the Research
Performance Progress Report (RPPR) in accordance with the final NIH
Policy for Data Management and Sharing to promote the management and
sharing of scientific data generated from NIH-funded or conducted
research. The progress report forms will be updated to align with this
requirement. The Training Data Tables will also be updated to reduce
the burden and promote consistent information collection, including
limiting the scope of information collection to data only relevant to
the training stage(s) of the proposed program in Table 1 and removing
instructions in Table 8 that are reported within the RPPR. Effective
May 2025, NIH will be adopting the Common Forms for Biographical Sketch
and Current and Pending (Other) Support as part of the directive from
Guidance for Implementing National Security Presidential Memorandum
(NSPM)-33. The Common Forms are part of a separate OMB collection,
currently approved under 3145-0279. As such, elements collected within
the Common Forms will be removed from NIH's current NIH Biosketch and
Other Support formats. NIH will continue to collect additional
information not captured on the Common Forms to adhere to the agency's
implementation of the NIH Peer Review Regulations at 42 CFR part 52 as
part of the NIH Biosketch form, which will be renamed the NIH Biosketch
Supplement to reflect the supplemental information requested. The
application and progress
[[Page 45001]]
report forms and associated instructions will be updated to align with
these new requirements. The RPPR is required to be used by all NIH,
Food and Drug Administration (FDA), Centers for Disease Control and
Prevention, and Agency for Healthcare Research and Quality (AHRQ)
grantees. Interim progress reports are required to continue support of
a PHS grant for each budget year within a competitive segment. This
collection also includes other PHS post-award reporting requirements:
PHS 416-7 National Research Service Award (NRSA) Termination Notice,
PHS 2271 Statement of Appointment, 6031-1 NRSA Annual Payback
Activities Certification, HHS 568 Final Invention Statement and
Certification, and PHS 3734 Statement Relinquishing Interests and
Rights in a PHS Research Grant. The PHS 416-7, 2271, and 6031-1 are
used by NRSA recipients to activate, terminate, and provide for payback
of an NRSA. Closeout of an award requires a Final Invention Statement
(HHS 568) and a Final Progress Report. The PHS 3734 serves as the
official record of grantee relinquishment of a PHS award when an award
is transferred from one grantee institution to another. Pre-award
reporting requirements are simultaneously consolidated under 0925-0001
and the changes to the collection here are related.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 579,365.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Information collection forms Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
REPORTING
----------------------------------------------------------------------------------------------------------------
PHS 416-7....................................... 12,580 1 30/60 6,290
PHS 6031-1...................................... 1,778 1 20/60 593
PHS 568......................................... 11,180 1 5/60 932
PHS 2271........................................ 22,035 1 15/60 5,509
PHS 2590........................................ 243 1 18 4,374
RPPR-Core Data.................................. 32,098 1 8 256,784
Biosketch (Part of RPPR)........................ 2,544 1 2 5,088
Data Tables (Part of RPPR)...................... 758 1 4 3,032
Trainee Diversity Report (Part of RPPR)......... 480 1 15/60 120
PHS Human Subjects and Clinical Trial 6,420 1 3 25,680
Information....................................
Publication Reporting........................... 97,023 3 5/60 24,256
Final RPPR--Core Data........................... 18,000 1 10 180,000
Data Tables (Part of Final RPPR)................ 758 1 4 3,032
Trainee Diversity Report (Part of Final RPPR)... 480 1 15/60 120
PHS Human Subjects and Clinical Trial 3,600 1 4 14,400
Information (Part of Final RPPR)...............
PHS 3734........................................ 479 1 30/60 240
Data Management and Sharing Plan (Part of RPPR). 15,649 1 2 31,298
Data Management and Sharing Plan (Part of Final 8,621 1 2 17,242
RPPR)..........................................
---------------------------------------------------------------
Reporting Burden Total...................... .............. .............. .............. 578,990
----------------------------------------------------------------------------------------------------------------
RECORDKEEPING
----------------------------------------------------------------------------------------------------------------
SBIR/STTR Life Cycle Certification.............. 1,500 1 15/60 375
---------------------------------------------------------------
Grand Total................................. 236,226 .............. .............. 579,365
----------------------------------------------------------------------------------------------------------------
Dated: May 9, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-11256 Filed 5-21-24; 8:45 am]
BILLING CODE 4140-01-P
